BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADIERE FORCEPS INSTRUMENT

    MDR report key: 971700 · Received December 21, 2007

    Report

    Report Number
    2955842-2007-00539
    Event Type
    Malfunction
    Date Received
    December 21, 2007
    Report Date
    December 21, 2007
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THE DISTAL END OF THE MAIN TUBE TO HAVE A COUPLE OF NARROW SECTIONS CONCENTRATED ON ONE SIDE OF THE TUBE WITH MATERIAL REMOVED. THE DAMAGED SECTIONS RANGE FROM .350- .950" IN LENGTH AND .060- .075" IN WIDTH. THE MATERIAL REMOVAL IS NOT SEVERE, BUT THERE IS A CHANGE IN SURFACE ROUGHNESS COMPARED TO THE REMAINDER OF THE TUBE. THE DAMAGED SECTIONS ARE PARALLEL TO THE TUBE AXIS, HOWEVER, THERE ARE GAPS BETWEEN THE SECTIONS, SUGGESTING MULTIPLE INSTANCES OF SCRAPING OCCURRED. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE MAY HAVE BEEN CAUSED BY A CANNULA ACCESSORY. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHARDS WERE FOUND ON THE SHAFT OF THE CADIERE FORCEPS INSTRUMENT. NO ADD'L INFO WAS PROVIDED. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADIERE FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420049-05 1210072 674

    Patients

    Seq Age Sex Outcome Treatment
    1 YR AND ACCESSORIES.| DA VINCI S SURGICAL SYSTEM